TKI258 v sorafenib in metastatic renal cell carcinoma PA02 090211

• Research type

  Research Study

• Full title

  An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor) therapies

• IRAS ID

  77872

• Contact name

  Paul Nathan

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2009-015459-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study compares the activity of a new targeted therapy TKI258, with sorafenib, a standard agent, in patients with metastatic renal cell carcinoma who have failed therapy with previous anti-angiogenic and mTor therapies. This is a multicentre international randomised open label phase III study in which patients will be allocated either to oral treatment with TKI258 500 mg/day po for 5 day on/2 day off) or to oral sorafenib (800 mg/day). Patients will be seen and examined by the study doctor at regular intervals and blood samples collected. Pharmacokinetic blood samples will also be collected from the TKI258 patients. CT or MRI scans will be repeated 8 weekly up to 12 months and then 12 weekly, thereafter. Further ECG, and echocardiogram or MUGA scans will be performed to monitor heart function. Patients will continue treatment until their disease progresses or they withdraw or are withdrawn from the trial. On completion of the trial, they will return to the clinic for the end of trial assessments. Patient survival will be followed up every 8 weeks until the trial completes (when 386 deaths have been recorded). Patients who discontinue treatment for reasons other than disease progression will continue to have scans until disease progression. Through separate consent processes, archival tumour tissue sample and blood will undergo pharmacogenetic analysis.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/0548

• Date of REC Opinion

  27 Jun 2011

• REC opinion

  Further Information Favourable Opinion